CUSTOMER STORIES
PharmaLex
A technology-enabled solution provider for pharma & biotech companies, uses DocShifter to accelerate compliant PDF conversion of submission content.
Ensuring confidence beyond compliance with DocShifter
Reducing manual work, and the associated costs & risks
PharmaLex, a technology enabled solution provider in the Life Sciences industry, has chosen DocShifter to speed up and automate the preparation of submission-ready PDF documents for their 1000 clients worldwide.
PharmaLex was previously using licensed PDF plug-in tools to prepare content for inclusion in submissions. The process of converting the original source documents to fully compliant submission-ready documents was complex, manual and extremely time-consuming.
Due to the volume (thousands of documents every year) and complexity (different document sizes, multiple formats such as Word, PDF, scanned PDF, etc.) of documents, the PharmaLex team has decided to streamline and rationalise the tools used, and make the switch to DocShifter.
DocShifter works directly with PharmaLex’s submission management system, picks up the original source documents, creates the compliant PDF renditions (simultaneously for either one, or multiple HAs), and uploads the compliant PDFs back into the submission management system, ready for compiling into the submission publishing tool. This allows the PharmaLex team to avoid resource intensive tasks, save time on the critical path, reduce cost, reduce the risk of non-compliance, and provide better and faster document publishing services. All while maintaining essential quality and compliance.
The DocShifter impact
30% faster time to market
By automating time consuming document merging / report compilation process, this company is now processing medical device submissions faster than ever; accelerating time to market.
60% time savings
The manual effort of previously merging tens or hundreds of documents into one or multiple PDFs is now long gone; resulting in significant time savings for the regulatory operations team.
40% faster results
40% reduction in document processing time, translating into substantial cost savings. The accelerated time to market, combined with enhanced compliance and productivity, resulted in a significant return on investment.
Efficiency gains in automated PDF report generation in medical devices
Designed for Merging Documents into Compliant PDF reports
DocShifter Reports+ is designed to create navigation-rich, searchable, fully technically compliant PDF reports by merging documents into single or multiple PDFs. It is highly scalable, and integrates with your existing systems or workflows. Natively, or using web API.
The software is highly configurable; more than 200 settings allows configurations on how you want to configure your PDF reports. These settings include but are not limited to: creating cover pages, table of contents/tables/figures, merging or splitting documents, pagination, watermarks, headers & footers, image encoding, embedding fonts and many more.
Improved Efficiency and Productivity
The automation capabilities of DocShifter eliminated the need for manually merging documents into one or more PDF reports, and then further manipulating those PDF reports for compliance.
The process is now streamlined with DocShifter. Both merging documents into PDF reports; and ensuring PDF compliance happens in DocShifter. Fully automated; saving valuable time for the regulatory operations team.